Probiotics to reduce weight gain from antipsychotic medications
: EFFECT OF PROBIOTIC SUPPLEMENTATION ON ATYPICAL ANTIPSYCHOTIC INDUCED WEIGHT GAIN IN PATIENTS ATTENDING PSYCHIATRIC CLINICS AT AINSHAMS UNIVERSITY HOSPITALS (A RANDOMIZED CONTROLLED TRIAL)
This study is testing if taking probiotics can help adults with schizophrenia avoid weight gain from their antipsychotic medications.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo, Abbassia) |
| Trial ID | NCT06936137 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of probiotic supplementation in reducing weight gain associated with atypical antipsychotic medications in adult patients diagnosed with schizophrenia. The study will involve a randomized controlled design, where participants will receive lactobacillus LS to assess its impact on weight and psychological well-being. The primary objective is to evaluate the reduction in weight gain, while the secondary objective focuses on the psychological state of the patients. The trial aims to enhance treatment compliance and overall quality of life for patients on antipsychotic medications.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-45 with schizophrenia who have gained more than 10% of their body weight after starting atypical antipsychotics.
Not a fit: Patients with gastrointestinal diseases or those currently taking probiotics, fiber supplements, antibiotics, or laxatives may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help patients manage weight gain caused by antipsychotic medications, improving their overall health and treatment adherence.
How similar studies have performed: While the specific approach of using probiotics for this purpose may be novel, there is existing research indicating potential benefits of probiotics in managing weight and psychological health.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult schizophrenia patients (18-45 years) on second generation antipsychotics Stable patients with a total positive and negative syndrome scale (PANSS) score of ≤60. With more than 10% weight gain after taking atypical antipsychotics for at least 3 months with treatment duration not more than two years. Exclusion Criteria: 1. Taking probiotics, fiber supplements, antibiotics and laxatives in the last 6 weeks. 2. Comorbid gastrointestinal diseases, including active peptic ulcer, uncontrolled and recurrent diarrhea, gastrointestinal bleeding, and digestive system neoplastic diseases. \-
Where this trial is running
Cairo, Abbassia
- AinShams university hospitals — Cairo, Abbassia, Egypt (Recruiting)
Study contacts
- Study coordinator: Rehab Abdelmaksoud
- Email: rehab.abdelmaksoud@med.asu.edu.eg
- Phone: 02 01158336110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.